CITRUS, cervical cancer screening trial by randomization of HPV testing intervention for upcoming screening: Design, methods and baseline data of 18, 471 women. (October 2017)

• Record Type: Journal Article
• Authors: Morisada, Tohru; Teramoto, Katsuhiro; Takano, Hirokuni; Sakamoto, Ikuko; Nishio, Hiroshi; Iwata, Takashi; Hashi, Akihiko; Katoh, Ryohei; Okamoto, Aikou; Sasaki, Hiroshi; Nakatani, Eiji; Teramukai, Satoshi; Aoki, Daisuke
• Is Part Of: Cancer epidemiology. Volume 50: Part A(2017:Oct.)
• Page Start: 60
• Page End: 67
• Publication Date: 2017-10
• Subjects: AGC atypical glandular cells -- AIS adenocarcinoma in situ -- ASC-H atypical squamous cells cannot exclude an HSIL -- ASC-US atypical squamous cells of undetermined significance -- CIN cervical intraepithelial neoplasia -- DNA deoxyribonucleic acid -- HPV human papillomavirus -- HSIL high-grade squamous intraepithelial lesion -- JSCC Japanese Society of Clinical Cytology -- LSIL low-grade squamous intraepithelial lesion -- NILM negative for intraepithelial lesion or malignancy -- SCC squamous cell carcinoma -- SIL squamous intraepithelial lesion; Cervical cancer -- Cytology -- Human papillomavirus DNA test -- Mass screening; Cancer -- Epidemiology -- Periodicals; Cancer -- Prevention -- Periodicals; Cancer -- Diagnosis -- Periodicals; Carcinogenesis -- Periodicals; 616.994005
• DOI: 10.1016/j.canep.2017.07.017
• Languages: English
• ISSNs: 1877-7821

Abstract

Highlights: Compared to the Western countries, the scientific evidences of effectiveness of HPV-based cervical cancer screening is limited in Japan. We initiated a randomized trial entitled CervIcal cancer screening Trial by Randomization of HPV testing intervention for Upcoming Screening (CITRUS). Insights from CITRUS will provide future prospects for cervical cancer screening focused on the use of HPV testing. Abstract: Background: To assess the efficacy of screening with concurrent liquid-based cytology and human papillomavirus (HPV) testing for primary cervical cancer screening, we initiated a randomized trial entitled CervIcal cancer screening Trial by Randomization of HPV testing intervention for Upcoming Screening (CITRUS). Methods: Between June 2013 and March 2015, women aged 30–64 years of age who participated in a regular cervical cancer screening program (every 2 years) were invited to enrollment of our study. After giving their informed consent, 18, 402 women were randomly assigned to liquid-based cytology as the control group (n = 9145) or to HPV DNA testing with liquid-based cytology as the intervention group (n = 9257). We subsequently compared the incidence rate of cervical intraepithelial neoplasia (CIN), the rate of false positive tests and the rate of overdiagnosis, as well as assessing the risks and benefits of receiving screening for women in both groups. The primary outcome of our study was the incidence of cervical intraepithelial neoplasia grade 3 or worse (CIN3+) during the study period of around 6 years. Results: In the control group, 97.9% of women were NILM, and 2.06% ASC-US or worse (ASC-US+). In the intervention group, 87.13% of women were NILM/HPV negative, 0.72% ASC-US/HPV negative, 10.34% NILM/HPV positive, 0.69% ASC-US/HPV positive, 0.90% worse than ASC-US/either HPV. Positive HPV testing was not linearly related to age in our study. Conclusions: Insights from CITRUS will provide future prospects for cervical cancer screening focused on the use of HPV testing in Japan. Clinical trial registration number: NCT01895517, UMIN000010843, TRIUC1312.